MAUDE Adverse Event Report: AESCULAP AG VEGA PS REMOVABLE TRIAL FEMUR BOX F4; INSTRUMENTS FOR KNEE ENDOPROST

Model Number	NS824R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a vega ps removable trial femur box f4 (part # ns824r) was used during a total hip arthroplasty (tha) procedure performed on (b)(6) 2021.According to the complainant, the edge of the trial was damaged when the doctor hit it with the hammer.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: one connector has been broken off from the device.The breakage surface of the device as well as that of the broken part (connector) show no material deviations like foreign material inclusions or any blow holes.Due to the small fracture surfaces it is hardly possible to carry out a fracture graphic examination.Nevertheless there are visible signs of a transgranular forced fracture.It can be assumed that the device was hammered in too hard because the slot for the femur box was not well prepared and therefore the device was mechanically overloaded.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 7(10 x probability of occurrence 3(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: VEGA PS REMOVABLE TRIAL FEMUR BOX F4
• Common Device Name: INSTRUMENTS FOR KNEE ENDOPROST
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12353864
• Report Number: 9610612-2021-00570
• Device Sequence Number: 6754263
• Product Code: HWT
• UDI-Device Identifier: 04046963998141
• UDI-Public: 4046963998141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NS824R
• Device Catalogue Number: NS824R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female